50 micrograms/dose nasal spray, suspension
fluticasone propionate
1. What Flutikason Teva is and what it is used for
Fluticasone Teva is a cortisone preparation, which counteracts inflammation and allergies even in very small doses.
Fluticasone Teva is used for colds and nasal congestion caused by allergies to, for example, pollen (so-called hay fever), animals, or dust. Fluticasone Teva can also be used for runny nose, nasal congestion, and sneezing without an allergic cause (so-called vasomotor runny nose ), but not for common cold runny nose.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
Fluticasone propionate contained in Fluticasone Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Flutikason Teva
Do not use Flutikason Teva
If you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Fluticasone Teva does not have an immediate effect, but the full effect is only achieved after a few days of regular use. In case of hay fever, the treatment should, if possible, be started before the pollen season begins.
In case of allergic symptoms from the eyes or during the first days when using Flutikason Teva, additional treatment may be needed.
If you are already taking cortisone (for inhalation, tablets, or cream/ointment) for example asthma or eczema, do not use Flutikason Teva without consulting your doctor.
Talk to your doctor before using Flutikason Teva if you have any of the following conditions:
- fungal or herpes infection in the nose
- if you have a fever or infection in your nose or sinuses
- recently had surgery on the nose or has injured the nose or has sores in the nose
- pulmonary tuberculosis
- severe liver disease
Contact a doctor if you experience blurred vision or other visual disturbances while using Flutikason Teva.
Other medicines and Flutikason Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Flutikason Teva is used at the same time as certain other medicines, the risk of side effects may increase. This applies to e.g. when using:
- ketoconazole and itraconazole (for fungal infections)
- erythromycin ( antibiotics )
- ritonavir and cobistat (for HIV ).
Your doctor may want to monitor you closely if you are taking these medicines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There is limited experience with the use of Flutikason Teva during pregnancy.
Breast-feeding
It is unknown whether Flutikason Teva passes into breast milk.
Driving and using machines
There are no studies on whether Flutikason Teva affects the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Fluticasone Teva contains benzalkonium chloride
Fluticasone Teva contains 40 micrograms of benzalkonium chloride solution in each dose.
Benzalkonium chloride may irritate and swell inside the nose, especially with prolonged use of the medicine.
3. How to use Flutikason Teva
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage for adults and children from 12 years: 1-2 sprays in each nostril once daily for a maximum of 3 months. This dosage should not be exceeded.
Start with 2 sprays in each nostril once a day, preferably in the morning. When you have improved and the symptoms are under control, the dose is reduced by one to 1 spray in each nostril once a day.
Fluticasone Teva often provides relief after a few hours, but the full effect is only obtained after a few days of regular use.
If you have not improved after 14 days of regular use, consult a doctor.
Also, consult a doctor if the medicine needs to be used daily for more than 3 months.
Feel free to try to end the treatment if you think that the pollen season for you is over or if there are very low levels of pollen in the air.
Used not for children under 12 years old without the advice of a physician.
Shake the nasal spray before use.
Eye contact should be avoided.
See “Instructions for Use” at the end of this leaflet.
If you use more Flutikason Teva then you should
You must take a dose as stated on the package label or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Flutikason Teva:
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Flutikason Teva and contact a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- drop in blood pressure
These may be symptoms of severe hypersensitivity reaction s as angioedema, and anaphylaxis that is a very rare side effect is (may affect up to 1 in 10 000).
Very common (may affect more than 1 user in 10):
- Slightly blood-mixed nasal secretions.
Common (may affect up to 1 in 10 people):
- Dryness/irritation of the nose and throat.
- Headache.
- Unpleasant odor or taste of the drug.
Very rare (may affect up to 1 in 10,000 people):
- Sores in the nose, holes in the nasal septum. The cause of these side effects is unclear.
- Glaucoma ( glaucoma ), increased eye pressure, cataract (cataract).
Has been reported (occurs in an unknown number of users):
- Dimsyn.
Sneezing can occur immediately after spraying.
5. How to store Flutikason Teva
Do not store above 25 ° C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is fluticasone propionate 50 micrograms/dose.
- The other ingredients are anhydrous glucose, microcrystalline cellulose, carmellose sodium, phenylethyl alcohol, benzalkonium chloride solution, polysorbate 80, purified water.
What the medicine looks like and the contents of the pack
Brown-yellow glass bottle with dose pump. Packages of 60 (over-the-counter), 120, 150 and 360 (3×120) doses .
Not all pack sizes may be marketed.
Manufacturer
TEVA Czech Industries sro
Opava-Komàrov
Czech Republic
Instructions for use
Read the instructions for use carefully before using Flutikason Teva.
Preparation of the nasal spray:
Before using a new bottle of Flutikason Teva nasal spray or if the spray has not been used for a week, charge the pump by shaking the bottle and spraying in the air until an even shower is obtained.
Keep the bottle away from you when you test sprays in the air.
| Shake the bottle take off the transparent hat. Hold the spray bottle as in the picture it rests on your thumb and places your middle finger and index finger on each side of the tip of the bottle. Pump by pressing the middle finger and index finger downwards against the thumb. Repeat a few times. |
Use of the nasal spray:
Wipe the nasal applicator and put the plastic cap back on.
Do not exceed the dosage!
Cleaning:
Clean the white plastic part (nasal applicator) at least once a week. Clean it more often if it becomes clogged.
Do not poke with a needle or other sharp object in the nasal applicator. Show larger
If the nasal applicator “plugs in”, it can stay in hot water for a while. Then rinse with cold water and allow to air dry. Replace the parts.